Since I didn’t have work for my second job—office was closed for President’s Day—I thought I might as well start backfilling those annotations. I didn’t think I’d finish them, but at some point thought, Ah, what the hell.

I’m sure I’ve missed posts I should have included and included posts I should have missed, and some of my annotations are. . . odd, but the mess is now more or less complete as of today.

~~~

Another reason for doing this might have a little something to do with another bout of self-pique: yesterday I turned a bunch of my dissertation research into printer paper—did I really need to keep a copy of a DOE ELSI Contractor-Grantee Workshop from 1997?—and proceeded to have a mini-meltdown.

Nothing serious, and nothing I haven’t had experienced before.

It happens whenever I confront all of the work I have done and how little I have done with that work. If the paper of all of that research wasn’t wasted, it seems like the research itself was. Yes, I created a dissertation out of all of it, but beyond that, nothing.

Nothing.

The dissertation matters unto itself, but it’s also supposed to serve as the cliff from which one is to dive ever further into the work. And for me, it didn’t: I peered down from different overlooks (my bioethics fellowships), but ultimately backed away.

Reasons, reasons: I had my reasons, but those reasons were no good.

And so, periodically, I am reminded of what I tossed away when I walked away, and not having any good way to deal with that deliberate waste, I stew.

Today, at least, I did something productive—if not with my own work, at least with someone else’s.

My ire is focused on both the researchers and on the Proceedings of the National Academy of Sciences for engaging subjects in research without their knowledge and consent (the former) and not flagging this lack of consent in their publication (the latter).

Since the promulgation of the Nuremburg Code following the trial of Nazi doctors, informed consent has been a cornerstone of research ethics. The World Medical Association followed with its own guidelines in the early 1960s (revised many times since), and in 1974, the US Department of Health, Education, and Welfare (now Health & Human Services) promulgated 45 CFR 46 (also updated numerous times); the US regs were later reinforced by the Belmont Report.

Having written and designed this experiment myself, I can tell you that our goal was never to upset anyone. I can understand why some people have concerns about it, and my coauthors and I are very sorry for the way the paper described the research and any anxiety it caused. In hindsight, the research benefits of the paper may not have justified all of this anxiety.

and expect that your emotional sorriness makes up for your ethical sorriness.

Not that Kramer even gets the ethical problem: he’s sorry for the way the paper described the research and sorry that the results did not justify the anxiety, but nowhere is he sorry for violating the dignity of his subjects.

Which, by the way, is the whole point of the regs: the recognition and protection of the dignity of human beings.

And PNAS? Shame on them for publishing such egregiously unethical work.

A clinical experiment involving 1,300 premature infants at two dozen hospitals “failed to adequately inform parents” of the risks of the treatment, which included blindness, brain damage and death, according to a watchdog agency at the Department of Health and Human Services.

Where the hell was the Institutional Review Board (IRB)? If they do nothing else, IRB’s are to ensure that risks are clearly and correctly spelled out in the consent form.

“The consent form was written in a slanted way,” said Jerry A. Menikoff, director of the Office for Human Research Protections (OHRP), which found that the study was “in violation of the regulatory requirements for informed consent” required by federal law.

“They went out of their way to tell you that your kid might benefit,” he said in an interview. “But they didn’t give the flip side, which is that there is a chance your kid might end up worse off. You can’t have it both ways.”

To repeat, where the hell was the IRB?

They don’t design studies, don’t enroll subjects, don’t collect data; the IRB is there to review the study, make sure it is valid and designed to reveal reliable results, scrutinize the risk/benefit tradeoffs, and make sure the consent form gives potential subjects sufficient information of all of the above so that they can make an informed decision of whether or not to participate.

Absent that information, it cannot be said that subjects gave informed consent.

The study was an important one—what is the optimal range of oxygen to be given to premature infants to ensure survival—and apparently yielded significant results which will lead to changes in the treatment of preemies. That good information was extracted from the research does not, however, justify the slipshod manner in which subjects were enrolled.

The consent form made a big point that all babies would get oxygen within the “acceptable” range of 85 to 95 percent. It noted that babies in the lower range might have less eye damage. But it didn’t mention that those in the higher range might have more eye damage. And there was no mention that in the days before oximetry — when oxygen was measured more crudely — that premature infants that got higher concentrations of oxygen tended to have greater survival, although often at the cost of their eyesight.

Instead, the only risk the consent form mentioned was skin irritation from the oximeter device, a trivial problem.

What wasn’t made clear to parents was that the study created two groups of babies with different treatments — although both fell within “standard of care” treatment — for which the researchers expected there would be different outcomes. That was the point of the study.

No mention of serious risk. No clear discussion of differential treatment. These are basic basic basic components of any minimally-decent informed consent form.

People associated with SUPPORT defended the consent form and noted that it was approved by 23 “institutional review boards’” (IRBs), which are the committees each research hospital must have to oversee the design and ethics of medical studies involving human beings.

“I don’t have any regrets. Everybody went into this with their best intention. Nobody was trying to deceive anybody,” said Neil N. Finer, a neonatologist at the University of California at San Diego who ran the trial.

Excuse me while I scream GOOD INTENTIONS ARE NOT ENOUGH! It is not about the intentions of the researchers, but about their actions and, importantly, about the well-being of the subjects themselves.

Those IRBs should be re-organized, re-constituted, and all members and researchers retrained as to the conduct of ethical research.

Celltex has responded by sending a letter to Eric Kaler, president of the University of Minnesota alleging misdeeds by Turner, and ending with the following:

Please inform us at your earliest convenience whether Associate Professor Turner’s February 21st letter, on the University’s letterhead, was authorized by the University. If it was not authorized, please inform us of what steps the University will take to disclaim any sponsorship of the Turner letter, retract the letter, remove the letter from the internet, prevent further distribution of the letter, and prevent recurrence of this type of action by Associate Professor Turner (or any other University professor). We wish to limit legal liability to those responsible for the wrongful acts and appreciate your cooperation in that regard.

Yeah, no.

Now, at this point I must admit that I know Leigh Turner—I worked with him at McGill—and like and greatly respect him. Leigh is a methodical thinker and researcher and, unlike your erratic and absurd host, not at all prone to popping off.

I also have to say that I found out about this SLAPP-suit at Carl Elliott’s blog, that I know, like, and greatly respect Carl, AND that I know, like, and greatly respect a number of the people who have also written to the FDA in support of Leigh.

(I also admit that I disclose these connections not just for reasons of honesty but because I think these people are terrific and am glad I know them.)

Anyway, read through the comments at Carl’s post and you’ll understand what I mean by “all hail Leigh Turner!” Note, for example, his patient and relentless responses to the evasive comments and personal attacks levelled by Laurence B. McCullough’s of the Center for Medical Ethics and Health Policy at Baylor College of Medicine. Leigh responds to every single point, respectfully requests additional information, and does. not. let. up.

Did I mention Leigh is methodical?

Okay, he does let one snipe go: McCullough at one point accuses Leigh of “American provincialism”; Leigh is Canadian.

In any case, Leigh has set a standard on how to respond to evasion, misdirection, and intimidation: know your stuff and don’t back down.

Complete and utter blog theft from Henry Farrell at Crooked Timber, but so nicely done, I couldn’t pass it up:

Gedankenexperiment

by Henry on November 29, 2011

Let’s imagine that we lived in an alternative universe where some of the more noxious nineteenth century pseudo-science regarding ‘inverts’ and same-sex attraction had survived into the late twentieth and early twenty-first centuries. Let us further stipulate that the editor of a nominally liberal opinion magazine had published one purported effort to ‘prove’ via statistics that same-sex attraction was a form of communicable psychosis, which invariably resulted in national degeneracy when it was allowed to persist. One of this essay’s co-authors had chased sissies in his youth, but claimed he had not realized that this was homophobic; he also had occasion to observe the lack of real men on the streets of Paris, and to deplore the resulting sapping of virility in the French national character. His efforts, and the efforts offellowresearchers (all of the latter funded by and/or directly involved with the Institute for the Suppression of Homosexual Filth) succeeded in creating a significant public controversy. Some public commentators embraced the same-sex-attraction-as-psychosis argument because they were, themselves, homophobes, others more plausibly because they were incompetent, or because they enjoyed being contrarians, or both. This, despite the fact that the statistical arguments on which these extreme claims depended were demonstrably incompetent.

Now, let us suppose that the same editor who helped release this tide of noxious homophobia in the first place still played a significant role in American public debate, and still refused to recognize that he might, actually, be wrong on the facts. . . .

I wonder, if we lived in such a world, what Andrew Sullivan would think of that editor?

A fine response to Sully’s inability not only to wipe the shit from his shoes, but even to admit he stepped in it.

There are, of course, substantive responses to Mr. Sullivan’s flogging the pc-egalitarianism-is-killing-research-into-racial-differences-in-IQ-and-I-am-brave-for-pointing-the-way-to-truth-justice-and-the-American-way line he periodically burps up, even while admitting that “I certainly don’t have profound knowledge of the deep research of experts in the field.”

Or, you know, any knowledge, beyond that of an editor publishing the execrable Murray-Herrnstein “bell curve” thesis that blacks are dumber than whites (even as he complains that “No one is arguing that ‘that black people are dumber than white,’ “—oh yes, Mr. Andrew, these two ‘no ones’ did exactly that).

Anyway, here’s the entire stupid thread thus far (original, response, response, response, response), as well as smart rebuttals by TNC here and here (read especially the comments for links to research from people who do have “profound knowledge” of the field).

In any case anyone is listening, yes, I believe that intelligence has a biological substrate, that evidence points to a multifactorial construction of intelligence, and that as a general matter there are genetic differences across populations, differences worth studying.

But that’s a damn sight away from sloppily heated declamations on race and IQ, refusal to consider the definitional (and thus methodological) problems with the terms “race” and “intelligence”, or, for that matter, on the role of “truth” in the research enterprise.

Ah, yes. Another stunning allegory from William Saletan. He’s just discovered that scientists find fetal tissue useful, and wonders why arguments in favor of human embryonic stem cell (hESC) research aren’t similarly applied to research on fetuses.

What he neglects is that federal guidelines on fetal research have long been in place (here’s the relevant statute, revised in 2005; see subpart B), as well as being subject to ethical and political skirmishes (regarding, for example, the admissibility of transplants of fetal material; cf. then-Secretary of HHS Sullivan’s rulings in the late 1980s).

So what’s new in what Saletan has to say? Not much.

I guess he’s going after the rhetoric: Those in favor of hESC research tend to argue for the urgency of such research: It’ll save lives! It’ll improve quality of life! We’ll learn so much more about human development. . . which will help us save lives and improve the quality of life!

If this is the case for hESC research, he wonders, why aren’t those in favor of research on fetuses making similar claims?

Well, in some cases, they have (I’ll have to dig out the cites), but these were arguments made years and decades ago. More to the point, perhaps, is precisely what Saletan both highlights and elides: Partisans in the hESC debate deploy rhetoric strategically (disassembling a blastocyst versus dismembering a human being), such that those who favor fetal research are likely not to want to trumpet a line of research which would create rhetorical openings to those opponents.

After all, many people distinguish between the status of an embryo and that of the fetus, such that most folks (if you trust poll data) don’t see embryo destruction as equivalent to dismemberment, while harvesting tissue from a fetus might seem, mm, grotesque.

Thus the reaction of Rod Dreher at Crunchy Con, who theorizes that fetal research will lead to the mining and cannibalization of babies.

As I point out in the comments to his initial post, however, I question the logic which links the harvesting of cadaveric fetal tissue to cannibalization—not least because he doesn’t consider how this situation is any different from the harvesting of adult cadaveric tissue for research and transplantation.

In other words, as grotesque as research on cadaveric fetal tissue may appear, it’s not clear to me that it is in kind any different from research on any other cadaver-derived tissue. The only difference is what led to the availability of that tissue: Abortion, in the first case, and death caused by accident or disease.

I have my own questions regarding transplantation and the pressures to donate (or create a market for) tissues and organs, and generally think skepticism ought to be applied to any claims of Imminent Medical Breakthroughs! That said, I think that those who criticize fetal-tissue research exclusively are unwilling to allow that there could be any medical-social benefits from abortion.

They might truly be appalled by research on fetuses. I simply wonder why they are not similarly appalled by research on adults.